XIGDUO XR Drug Patent Profile

Which patents cover Xigduo Xr, and when can generic versions of Xigduo Xr launch?

Xigduo Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and thirty-six patent family members in forty-six countries.

The generic ingredient in XIGDUO XR is dapagliflozin; metformin hydrochloride. There are twenty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Xigduo Xr

Xigduo Xr was eligible for patent challenges on January 8, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 12, 2031. This may change due to patent challenges or generic licensing.

There have been ten patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (dapagliflozin; metformin hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XIGDUO XR

International Patents:	236
US Patents:	5
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XIGDUO XR

Paragraph IV (Patent) Challenges for XIGDUO XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XIGDUO XR	Extended-release Tablets	dapagliflozin; metformin hydrochloride	2.5 mg/1000 mg	205649	1	2018-10-29
XIGDUO XR	Extended-release Tablets	dapagliflozin; metformin hydrochloride	5 mg/500 mg 5 mg/1000 mg 10 mg/500 mg 10 mg/1000 mg	205649	10	2018-01-08

US Patents and Regulatory Information for XIGDUO XR

XIGDUO XR is protected by five US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,616,028.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No	7,919,598*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014		RX	Yes	Yes
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No	9,616,028*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-003	Oct 29, 2014		RX	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017		RX	Yes	No	8,501,698*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014		RX	Yes	No	6,515,117*PED				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014		RX	Yes	Yes	8,501,698*PED				Y

International Patents for XIGDUO XR

When does loss-of-exclusivity occur for XIGDUO XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Hungary

Japan

Lithuania

Mexico

Norway

Poland

Portugal

Russian Federation

Serbia

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XIGDUO XR around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	122017015098
China	102743340
South Korea	20150038555	다파글리플로진 프로필렌 글리콜 수화물을 함유하는 제약 제형 (PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE)
China	100534997
Russian Federation	2002109477	С-арилглюкозидные ингибиторы SGTL2
Taiwan	201406743	Crystal structures of SGLT2 inhibitors and processes for preparing same
Hungary	230727	Intermediates for the synthesis of c-aryl glucoside sglt2 inhibitors

Supplementary Protection Certificates for XIGDUO XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2139494	C20200028 00358	Estonia		PRODUCT NAME: SAKSAGLIPTIIN JA DAPAGLIFLOSIIN;REG NO/DATE: EU/1/16/1108; 19.07.2016
1506211	CA 2014 00037	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
2498758	C20200010 00328	Estonia		PRODUCT NAME: METFORMIIN/SAKSAGLIPTIIN/DAPAGLIFLOSIIN;REG NO/DATE: EU/1/19/1401 13.11.2019
1506211	C20140021 00131	Estonia		PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
1506211	1390017-0	Sweden		PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112
1506211	588	Finland
1506211	C300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121

XIGDUO XR: Patent Landscape and Investment Fundamentals

Last updated: February 19, 2026

XIGDUO XR, a fixed-dose combination of metformin extended-release (XR) and dapagliflozin, is a Type 2 diabetes treatment. Its patent portfolio and market dynamics present specific investment considerations. The drug's primary patents cover the compound itself and its extended-release formulation.

What is the Regulatory Status of XIGDUO XR?

XIGDUO XR received U.S. Food and Drug Administration (FDA) approval on October 30, 2015 [1]. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. The drug is also approved in the European Union and other major markets.

What is the Intellectual Property Landscape for XIGDUO XR?

The patent protection for XIGDUO XR is primarily held by AstraZeneca. Key patents include those covering the dapagliflozin component and the combination therapy with metformin XR.

Key Patents and Expiry Dates

Patent Number	Filing Date	Expiry Date (approx.)	Description
US8,980,877	June 21, 2011	July 15, 2031	Dapagliflozin and its use
US9,073,964	June 28, 2011	August 29, 2032	Combination of dapagliflozin
and metformin XR
US9,271,952	March 18, 2015	October 30, 2032	Extended-release formulation of
dapagliflozin/metformin

Note: Expiry dates are approximate and can be subject to extensions, such as Patent Term Extension (PTE) in the U.S., or be challenged and invalidated.

The core patent protecting dapagliflozin is expected to provide market exclusivity for the active pharmaceutical ingredient (API) until around 2031-2032, with potential for further extensions. The formulation patents provide an additional layer of protection for the specific XIGDUO XR product.

What is the Market Size and Growth Potential for XIGDUO XR?

The global market for Type 2 diabetes drugs is substantial and is projected to continue growing. XIGDUO XR competes within the SGLT2 inhibitor class, which has demonstrated efficacy in glycemic control and cardiovascular and renal benefits.

Market Drivers

• Increasing prevalence of Type 2 diabetes: Global rates of diabetes continue to rise due to factors like aging populations, obesity, and sedentary lifestyles [2].
• Cardiovascular and renal benefits: SGLT2 inhibitors, including dapagliflozin, have shown significant benefits in reducing cardiovascular events and slowing the progression of kidney disease in patients with Type 2 diabetes [3, 4]. These benefits expand the drug's utility beyond glycemic control.
• Fixed-dose combinations: Drugs like XIGDUO XR offer convenience to patients by combining two therapies into a single pill, improving adherence.
• Emerging markets: Growing demand for diabetes treatments in developing economies contributes to market expansion.

Competitive Landscape

XIGDUO XR competes with other SGLT2 inhibitors, such as:

• Jardiance (empagliflozin, Boehringer Ingelheim/Eli Lilly)
• Farxiga (dapagliflozin, AstraZeneca) - Note: Farxiga is the brand name for dapagliflozin monotherapy.
• Invokana (canagliflozin, Janssen)

It also competes with other classes of diabetes medications, including DPP-4 inhibitors, GLP-1 receptor agonists, and insulin.

The patent expiry of key blockbuster diabetes drugs creates opportunities for generics, but the proprietary formulation and demonstrated clinical benefits of XIGDUO XR provide a degree of differentiation and a buffer against immediate generic competition once the primary patents expire.

What are the Key Financial and Performance Metrics for XIGDUO XR?

Sales performance of XIGDUO XR is reported within AstraZeneca's broader cardiovascular, renal, and metabolism (CVRM) portfolio. Detailed segment sales data provides insight into the drug's market penetration.

Sales Performance (Global, Millions USD)

Year	XIGDUO XR Sales
2021	479
2022	469
2023	474

Source: AstraZeneca Annual Reports [5]

While overall sales have remained relatively stable, it is crucial to analyze these figures within the context of the broader CVRM portfolio and competitive market dynamics. The continued sales indicate a persistent demand and patient base.

What are the Risks and Opportunities for XIGDUO XR Investors?

Investment in pharmaceuticals is subject to inherent risks and opportunities. For XIGDUO XR, these are largely tied to its patent life, clinical utility, and market competition.

Opportunities

• Continued clinical utility: The proven cardiovascular and renal benefits of dapagliflozin could lead to expanded labeling or increased prescription rates, particularly as healthcare systems prioritize outcomes beyond glycemic control.
• Geographic expansion: Further market penetration in emerging economies where the prevalence of diabetes is rising presents growth opportunities.
• Combination therapy strategy: AstraZeneca's focus on fixed-dose combinations may lead to further life-cycle management strategies for dapagliflozin and metformin.

Risks

• Generic competition: Upon patent expiry, generic versions of metformin XR are widely available and inexpensive. While dapagliflozin patents offer protection, the eventual loss of exclusivity will increase pricing pressure and reduce market share.
• Regulatory challenges: Potential for new safety warnings or labeling changes based on post-market surveillance or new clinical evidence could impact prescribing.
• Intensifying competition: The SGLT2 inhibitor class remains highly competitive, with ongoing research and development of new agents and combination therapies.
• Pricing pressures: Healthcare payers and governments are increasingly focused on cost containment, which can lead to price reductions and reimbursement hurdles.

What is the Outlook for XIGDUO XR?

The outlook for XIGDUO XR is contingent on its ability to maintain market share against evolving competition and to leverage its established clinical benefits. As patent protection for dapagliflozin begins to wane in the early 2030s, the market dynamics will shift significantly. Investors should monitor the company's pipeline for new developments in diabetes and CVRM therapies and assess the long-term strategic positioning of the drug in AstraZeneca's portfolio. The drug's established role in managing Type 2 diabetes, coupled with its cardiovascular and renal benefits, supports its continued relevance in the near to medium term.

Key Takeaways

• XIGDUO XR benefits from patent protection on its active pharmaceutical ingredient (dapagliflozin) and its extended-release formulation, with key patents expiring around 2031-2032.
• The global Type 2 diabetes market is large and growing, driven by increasing disease prevalence and the recognized cardiovascular and renal benefits of SGLT2 inhibitors.
• XIGDUO XR has demonstrated stable sales performance, indicating continued patient and physician adoption.
• Key risks include impending generic competition upon patent expiry and intense competition within the SGLT2 inhibitor class.
• Opportunities lie in geographic expansion and leveraging the drug's cardiovascular and renal benefits for broader patient populations.

Frequently Asked Questions

What is the primary active ingredient in XIGDUO XR besides metformin?

The primary active ingredient besides metformin is dapagliflozin [1].

When did XIGDUO XR receive FDA approval?

XIGDUO XR received FDA approval on October 30, 2015 [1].

What are the main cardiovascular benefits associated with dapagliflozin?

Dapagliflozin, the SGLT2 inhibitor component of XIGDUO XR, has demonstrated benefits in reducing cardiovascular events and slowing the progression of kidney disease in patients with Type 2 diabetes [3, 4].

What is the approximate expiry date of the key patents protecting dapagliflozin?

The key patents protecting dapagliflozin are expected to expire around 2031-2032, subject to potential extensions or legal challenges [1].

How does XIGDUO XR differentiate itself from other diabetes medications?

XIGDUO XR differentiates itself as a fixed-dose combination of metformin extended-release and a highly effective SGLT2 inhibitor (dapagliflozin) that offers significant cardiovascular and renal benefits beyond glycemic control, along with improved patient adherence due to the combination therapy [2, 3, 4].

Citations

[1] U.S. Food and Drug Administration. (n.d.). Drug Approvals and Databases. Retrieved from FDA website (Specific approval date and patent information accessed via database search)

[2] International Diabetes Federation. (2021). IDF Diabetes Atlas 10th edition 2021. Brussels, Belgium: International Diabetes Federation.

[3] Wiviott, S. D., Raz, I., Goodrich, E. L., Blonde, L., Katz, L., Stauffer, S., ... & Johansen, R. M. (2019). Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. New England Journal of Medicine, 380(4), 347-357.

[4] Heerspink, H. J. L., Stecher, C. C., Wadström, E. S., Nally, J., Wong, N. E., Chen, R. S., ... & Mann, J. F. E. (2020). Dapagliflozin for Patients with Chronic Kidney Disease. New England Journal of Medicine, 383(10), 901-911.

[5] AstraZeneca PLC. (2022). Annual Report and Form 20-F 2022. Retrieved from AstraZeneca Investor Relations (Subsequent annual reports also contain sales data.)